Reducing Inequity in the Use of Automated Insulin Delivery Systems by Adults With Type 1 Diabetes: Key Learnings From a Safety Net Diabetes Clinic Program.

BACKGROUND: Recent advancements in diabetes technology have significantly improved Type 1 diabetes (T1D) management, but disparities persist, particularly in the adoption of automated insulin delivery (AID) systems within minoritized communities. We aimed to improve patient access to AID system training and overcome clinical inertia to referral. METHODS: We report on a transformative program implemented at Boston Medical Center, the largest safety-net hospital in New England, aimed at reducing disparities in AID system utilization. We employed a multidisciplinary team and quality improvement principles to identify barriers and develop solutions. Strategies included increasing access to diabetes educators, creating a referral system, and developing telemedicine education classes. We also made efforts to raise clinician awareness and confidence in recommending AID therapy. RESULTS: At baseline, 13.5% of our clinic T1D population was using an insulin pump. The population referred included 97 people with T1D (49% female, mean A1c 8.7%, 68% public insurance beneficiaries, 25% Hispanic and 25% non-Hispanic Black). Results from the first year showed a 166% increase in AID system use rates, with 64% of referred patients starting on AID. Notably, 78% of patients with A1c >8.5% adopted AID systems, addressing a gap in representation observed in clinical efficacy trials. The initiative successfully narrowed disparities in AID use among minoritized populations. CONCLUSIONS: The program's success among minoritized patients underscores the significance of tailored, collaborative, team-based care and targeted educational initiatives. Our experience provides a foundation for future efforts to ensure equitable access to diabetes technologies, emphasizing the potential of local quality improvement interventions.

Optimizing Glycemic Outcomes for Minoritized and Medically Underserved Adults Living with Type 1 Diabetes.

Individuals living with type 1 diabetes (T1D) from medically underserved communities have poorer health outcomes. Efforts to improve outcomes include a focus on team-based care, activation of behavior change, and enhancing self-management skills and practices. Advanced diabetes technologies are part of the standard of care for adults with T1D. However, health care providers often carry implicit biases and may be uncomfortable with recommending technologies to patients who have traditionally been excluded from efficacy trials or have limited real-world exposure to devices. We review the literature on this topic and provide an approach to address these issues in clinical practice.

Proof-of-concept Application of Continuous Glucose Monitoring Data Analytics to Identify Diabetes Glucotypes.

Background: In this proof-of-concept study, we evaluated if monogenic diabetes resulting from mutations of the HNF-1α gene (HNF1A-MODY) has a distinctive continuous glucose monitoring (CGM) glucotype, in comparison to type 1 diabetes (T1D). Methods: Using CGM data from 5 subjects with HNF1A-MODY and 115 subjects with T1D, we calculated multiple glucose metrics, including measures of within- and between-day variability (such as coefficient variation for each hour [CVb_1h]). Results: The MODY and T1D cohorts had minimum CVb_1h of 11.3 ± 4.4 and 18.0 ± 4.9, respectively (P = .02) and maximum CVb_1h of 33.9 ± 5.0 and 50.3 ± 10, respectively (P < .001). All subjects with HNF1A-MODY had a minimum %CVb_1h ≤ 17.3% and maximum %CVb_1h ≤ 37.1%. In contrast, only 12 of 115 subjects with T1D had both a minimum and maximum %CVb_1h below these thresholds (P < .001). Conclusion: HNF1A- MODY is characterized by a low hourly, between-day glucose variability. CGM-derived glucose metrics may have potential applicability for screening for atypical diabetes phenotypes in the T1D population.

Diabetes Technology Meeting 2022.

Diabetes Technology Society hosted its annual Diabetes Technology Meeting from November 3 to November 5, 2022. Meeting topics included (1) the measurement of glucose, insulin, and ketones; (2) virtual diabetes care; (3) metrics for managing diabetes and predicting outcomes; (4) integration of continuous glucose monitor data into the electronic health record; (5) regulation of diabetes technology; (6) digital health to nudge behavior; (7) estimating carbohydrates; (8) fully automated insulin delivery systems; (9) hypoglycemia; (10) novel insulins; (11) insulin delivery; (12) on-body sensors; (13) continuous glucose monitoring; (14) diabetic foot ulcers; (15) the environmental impact of diabetes technology; and (16) spinal cord stimulation for painful diabetic neuropathy. A live demonstration of a device that can allow for the recycling of used insulin pens was also presented.

Making sense of glucose sensors in end-stage kidney disease: A review.

Diabetes mellitus remains the leading cause of end-stage kidney disease worldwide. Inadequate glucose monitoring has been identified as one of the gaps in care for hemodialysis patients with diabetes, and lack of reliable methods to assess glycemia has contributed to uncertainty regarding the benefit of glycemic control in these individuals. Hemoglobin A1c, the standard metric to evaluate glycemic control, is inaccurate in patients with kidney failure, and does not capture the full range of glucose values for patients with diabetes. Recent advances in continuous glucose monitoring have established this technology as the new gold standard for glucose management in diabetes. Glucose fluctuations are uniquely challenging in patients dependent on intermittent hemodialysis, and lead to clinically significant glycemic variability. This review evaluates continuous glucose monitoring technology, its validity in the setting of kidney failure, and interpretation of glucose monitoring results for the nephrologist. Continuous glucose monitoring targets for patients on dialysis have yet to be established. While continuous glucose monitoring provides a more complete picture of the glycemic profile than hemoglobin A1c and can mitigate high-risk hypoglycemia and hyperglycemia in the context of the hemodialysis procedure itself, whether the technology can improve clinical outcomes merits further investigation.

The Development of an Exercise Advisor App for Type 1 Diabetes: Digitization Facilitates More Individualized Guidance.

Maintaining blood glucose levels in the target range during exercise can be onerous for people with type 1 diabetes (T1D). Using evidence-based research and consensus guidelines, we developed an exercise advisor app to reduce some of the burden associated with diabetes management during exercise. The app will guide the user on carbohydrate feeding strategies and insulin management strategies before, during, and after exercise and provide targeted and individualized recommendations. As a basis for the recommendations, the decision trees for the app use various factors including the type of insulin regimen, time of activity, previous insulin boluses, and current glucose level. The app is designed to meet the various needs of people with T1D for different activities to promote safe exercise practices.

Use of Connected Pen as a Diagnostic Tool to Evaluate Missed Bolus Dosing Behavior in People with Type 1 and Type 2 Diabetes.

Objective: This study used connected pen to determine missed bolus dose (MBD) frequency during masked and unmasked continuous glucose monitoring (CGM) periods and examined its link with time-in-range (TIR), time-above-range (TAR), time-below-range (TBR), and key participant characteristics in people with diabetes. Methods: This was a 12-week, single-arm, exploratory, two-period study for people with type 1 diabetes (T1D) or type 2 diabetes (T2D). The primary objective was to estimate the average number of MBD during masked and real-time CGM use. The secondary objective was to estimate the average percent TIR and its relationship to MBD. An exploratory objective was to investigate the participant characteristics that were associated with MBD. Data were analyzed for differences in MBD by diabetes type and other participant characteristics, by CGM period, and by hypoglycemic fear scores. Results: Participants (n = 64; T1D, n = 38; T2D, n = 26) were 48 ± 11.9 years old and 44% were female. From the masked to the unmasked period, MBD, %TAR, %TBR, and glycated hemoglobin decreased significantly (0.74 MBD/day to 0.62 MBD/day, P = 0.008; 53.6%-48.1%, P = 0.004; 4.49%-2.93%, P < 0.001; mean 8.8%-8.4%, P < 0.001, respectively), while %TIR increased significantly (41.9%-49.0%, P < 0.001). MBD/day was negatively associated with TIR (P = 0.016) and positively associated with TAR (P = 0.015) for T1D and positively associated with TBR (P = 0.024) for T2D in the masked period only. MBD was significantly associated with fear of hypoglycemia for T2D, but not T1D. Conclusions: MBD is associated with reduced TIR when CGM is masked and tailored therapeutic approaches are needed for T1D and T2D populations.

Predictive Low-Glucose Suspend Necessitates Less Carbohydrate Supplementation to Rescue Hypoglycemia: Need to Revisit Current Hypoglycemia Treatment Guidelines.

Current guidelines recommend 15-20 g of carbohydrate (CHO) for treatment of mild to moderate hypoglycemia. However, these guidelines do not account for reduced insulin during suspensions with predictive low-glucose suspend (PLGS). We assessed insulin suspensions, hypoglycemic events, and CHO treatment during a 20-h inpatient evaluation of an investigational system with a PLGS feature, including an overnight basal up-titration period to activate the PLGS. Among 10 adults with type 1 diabetes, there were 59 suspensions; 7 suspensions were associated with rescue CHO and 5 with hypoglycemia. Rescue treatment consisted of median 9 g CHO (range: 5-16 g), with no events requiring repeat CHO. No rescue CHO were given during or after insulin suspension for the overnight basal up-titration. To minimize rebound hyperglycemia and needless calorie intake from hypoglycemia overtreatment, updated guidance for PLGS systems should reflect possible need to reduce CHO amounts for hypoglycemia rescue associated with an insulin suspension. The clinical trial was registered with ClinicalTrials.gov (NCT03890003).

Insulin Metrics: Need for Development of Consensus Standards for Reporting of Insulin Dosing Data.

The advent of connected insulin pens will generate an avalanche of digital insulin data, especially in the context of prandial- and multiple daily injection-insulin regimens. There is a need for the diabetes community to develop standards for such data, analogous to what has been achieved using the ambulatory glucose profile and associated metrics for glucose, permitting harmonization of data reporting for multiple devices and facilitating integration of glucose, insulin, food intake, and physical activity data. Several studies have estimated the timing of meals by analyses of glucose excursions but using diverse criteria. There is need for uniform criteria for multiple types of insulin boluses, including premeal, perimeal, delayed, missed, and correction boluses to facilitate research studies and patient care. This article contains a first preliminary proposal for standards regarding reporting of insulin dosing data. Clinical usage of these reports will require sensitive communication between health care providers and patients.

A daily study of stressors, continuously measured glucose, and diabetes symptoms in latinos with type 2 diabetes.

This study examined whether daily stressors and continuously monitored glucose levels and glucose variability predict daily diabetes symptoms. Fifty Latinos with type 2 diabetes were randomized to either diabetes education (DE-only; N = 23) or DE plus stress management and relaxation training (DE + SMR; N = 32). After treatment, for 7 days they wore 'blinded' continuous glucose monitors and reported common stressors and diabetes symptoms twice daily. Between individuals, participants with more numerous overall stressors and more time in hyperglycemia reported higher symptoms. Within individuals, symptoms were higher during intervals of greater than usual stressors. Yet, diabetes symptoms did not covary with changes in glucose levels or glucose variability. The within-person stressor-symptom association was stronger among older individuals and non-significant for participants in DE + SMR condition. Diabetes symptoms were associated with recent stressor exposure, but not recent glucose level or changes in glucose. CLINICAL TRIAL NUMBER: ClinicalTrials.gov Identifier (No. NCT01578096).

Performance of an Automated Insulin Delivery System: Results of Early Phase Feasibility Studies.

Background: Automated insulin delivery (AID) systems have demonstrated improvements in time-in-range (TIR, blood glucose 70-180 mg/dL) without increasing hypoglycemia. Testing a closed-loop system in an inpatient environment with supervised challenges allows for initial evaluation of performance and safety of the system. Methods: Adults with type 1 diabetes (T1D) were enrolled into two similar studies (n = 10 per study), with 3-day inpatient analysis periods. Participants tested a Lilly hybrid closed-loop (HCL) system comprising an investigational insulin pump, insulin lispro, a pump-embedded model predictive control algorithm, a continuous glucose monitor (CGM), and an external dedicated controller. Each protocol included meal-related and exercise challenges to simulate real-world diabetes self-management errors. Only study staff interacted with the HCL system. Performance was assessed using standard CGM metrics overall and within prespecified periods. Results: Participants (25% male) had mean ± standard deviation (SD) age 44.7 ± 14.2 years, T1D duration 30.2 ± 11.1 years, A1C 7.2% ± 0.8%, and insulin usage 0.53 ± 0.21 U/(kg·day). Percentage TIR 70-180 mg/dL (mean ± SD) was 81.2 ± 8.4 overall, 85.2 ± 8.1 outside of challenge periods, 97.3 ± 5.3 during the nocturnal periods, and 74.5 ± 16.2 for the postprandial periods. During challenge periods, percentage TIR for the overbolus challenge was 65.4 ± 29.2 and that for the delayed bolus challenge was 57.1 ± 25.1. No adverse events (AEs), serious AEs, or unanticipated adverse device events occurred while participants were using the HCL system. Conclusions: In participants with T1D, Lilly AID system demonstrated expected algorithm performance and safety with satisfactory glycemic outcomes overall and in response to simulated diabetes management challenges. Additional studies in less supervised conditions and with broader patient populations are warranted. ClinicalTrials.gov Registration number NCT03743285, NCT03849612.

Experiences of Adults With Type 1 Diabetes Using Glucose Sensor-Based Mobile Technology for Glycemic Variability: Qualitative Study.

BACKGROUND: Adults with type 1 diabetes (PWDs) face challenging self-management regimens including monitoring their glucose values multiple times a day to assist with achieving glycemic targets and reduce the risk of long-term diabetes complications. Recent advances in diabetes technology have reportedly improved glycemia, but little is known about how PWDs utilize mobile technology to make positive changes in their diabetes self-management. OBJECTIVE: The aim of this qualitative study was to explore PWDs' experiences using Sugar Sleuth, a glucose sensor-based mobile app and Web-based reporting system, integrated with the FreeStyle Libre glucose monitor that provides feedback about glycemic variability. METHODS: We used a qualitative descriptive research design and conducted semistructured interviews with 10 PWDs (baseline mean glycated hemoglobin, HbA1c) 8.0%, (SD 0.45); 6 males and 4 females, aged 52 years (SD 15), type 1 diabetes (T1D) duration 31 years (SD 13), 40% (4/10, insulin pump) following a 14-week intervention during which they received clinical support and used Sugar Sleuth to evaluate and understand their glucose data. Audio-recorded interviews were transcribed, coded, and analyzed using thematic analysis and NVivo 11 (QSR International Pty Ltd). RESULTS: A total of 4 main themes emerged from the data. Participants perceived Sugar Sleuth as an Empowering Tool that served to inform lifestyle choices and diabetes self-management tasks, promoted preemptive self-care actions, and improved discussions with clinicians. They also described Sugar Sleuth as providing a Source of Psychosocial Support and offering relief from worry, reducing glycemic uncertainty, and supporting positive feelings about everyday life with diabetes. Participants varied in their Approaches to Glycemic Data: 40% (4/10) described using Sugar Sleuth to review data, understand glycemic cause and effect, and plan for future self-care. On the contrary, 60% (6/10) were reluctant to review past data; they described receiving benefits from the immediate numbers and trend arrows, but the app still prompted them to enter in the suspected causes of glucose excursions within hours of their occurrence. Finally, only 2 participants voiced Concerns About Use of Sugar Sleuth; they perceived the app as sometimes too demanding of information or as not attuned to the socioeconomic backgrounds of PWDs from diverse populations. CONCLUSIONS: Results suggest that Sugar Sleuth can be an effective educational tool to enhance both patient-clinician collaboration and diabetes self-management. Findings also highlight the importance of exploring psychosocial and socioeconomic factors that may advance the understanding of PWDs' individual differences when using glycemic technology and may promote the development of customized mobile tools to improve diabetes self-management.

Evaluating a Glucose-Sensor-Based Tool to Help Clinicians and Adults With Type 1 Diabetes Improve Self-Management Skills.

BACKGROUND: The goal of this uncontrolled pilot study was to assess the feasibility of a self-care management mobile app, called Sugar Sleuth, which incorporates the FreeStyle Libre™ glucose sensor, to help clinicians and people with type 1 diabetes (PWD) identify and mitigate self-care behaviors that contribute to glucose variability. METHODS: PWDs with a baseline A1c between 7.5 and 9.0% used the mobile app for 14 weeks. The app prompted the PWD to enter the suspected cause of detected glycemic excursions, and to record food and insulin information. PWDs met with clinicians to collaboratively review data, identify challenges, and devise a specific self-care plan. Outcome measures included a single glycemic outcome score (SGOS) and attitude rating scales to better understand how participant attitudes could affect glycemic outcome. RESULTS: Thirty enrolled PWDs had a mean age of 55 ± 2.6 years, and a mean diabetes duration of 32 ± 2.9 years. A significant average reduction in A1c of 0.5 ± 0.07% ( P < .01) and in mean daily carbohydrate intake of 43 ± 21 grams ( P = .05) was found. No statistically significant change in glycemic metrics, body weight, or total daily insulin dose was found. A significant negative association occurred between SGOS and "hypoglycemia tolerance" ( P = .04), and a positive correlation occurred that approached significance with "motivation to change behavior" ( P = .06). CONCLUSIONS: These findings suggest that this mobile app system, in conjunction with CGM, provides a useful platform for helping clinicians and adults with T1D improve self-management skills to improve glycemic control.

Mini-Dose Glucagon as a Novel Approach to Prevent Exercise-Induced Hypoglycemia in Type 1 Diabetes.

OBJECTIVE: Patients with type 1 diabetes who do aerobic exercise often experience a drop in blood glucose concentration that can result in hypoglycemia. Current approaches to prevent exercise-induced hypoglycemia include reduction in insulin dose or ingestion of carbohydrates, but these strategies may still result in hypoglycemia or hyperglycemia. We sought to determine whether mini-dose glucagon (MDG) given subcutaneously before exercise could prevent subsequent glucose lowering and to compare the glycemic response to current approaches for mitigating exercise-associated hypoglycemia. RESEARCH DESIGN AND METHODS: We conducted a four-session, randomized crossover trial involving 15 adults with type 1 diabetes treated with continuous subcutaneous insulin infusion who exercised fasting in the morning at ∼55% VO2max for 45 min under conditions of no intervention (control), 50% basal insulin reduction, 40-g oral glucose tablets, or 150-µg subcutaneous glucagon (MDG). RESULTS: During exercise and early recovery from exercise, plasma glucose increased slightly with MDG compared with a decrease with control and insulin reduction and a greater increase with glucose tablets (P < 0.001). Insulin levels were not different among sessions, whereas glucagon increased with MDG administration (P < 0.001). Hypoglycemia (plasma glucose <70 mg/dL) was experienced by six subjects during control, five subjects during insulin reduction, and none with glucose tablets or MDG; five subjects experienced hyperglycemia (plasma glucose ≥250 mg/dL) with glucose tablets and one with MDG. CONCLUSIONS: MDG may be more effective than insulin reduction for preventing exercise-induced hypoglycemia and may result in less postintervention hyperglycemia than ingestion of carbohydrate.

Efficacy and Safety of Mini-Dose Glucagon for Treatment of Nonsevere Hypoglycemia in Adults With Type 1 Diabetes.

Context: Standard treatment of hypoglycemia is oral carbohydrate, but it often results in hyperglycemia and entails extra caloric intake. Objective: To evaluate low-dose glucagon to treat mild hypoglycemia in ambulatory adults with type 1 diabetes (T1D). Design: Randomized crossover trial (two 3-week periods). Setting: Five U.S. diabetes clinics. Patients: Twenty adults with T1D using an insulin pump and continuous glucose monitor (CGM) and experiencing frequent mild hypoglycemia. Intervention: Nonaqueous mini-dose glucagon (MDG) (150 µg) to treat nonsevere hypoglycemia. Main Outcome Measures: Successful treatment was defined as blood glucose (BG) ≥50 mg/dL 15 minutes and ≥70 mg/dL 30 minutes after intervention, on the study meter. Two authors, blinded to treatment arm, independently judged each event as a clinical success or failure. Results: Sixteen participants (mean age 39 years, 75% female, mean diabetes duration 23 years, mean hemoglobin A1c 7.2%) had 118 analyzable events with initial BG of 50 to 69 mg/dL. Successful treatment criteria were met for 58 (94%) of 62 events during the MDG period and 53 (95%) of 56 events during the glucose tablets (TABS) period (adjusted P = 0.99). Clinical assessments of success for these events were 97% and 96%, respectively. CGM-measured time in range did not differ between treatment groups during the 2 hours after events, but TABS resulted in higher maximum glucose (116 vs 102 mg/dL; P = 0.01) over the first hour. Conclusions: Low-dose glucagon can successfully treat mild hypoglycemia and may be a useful alternative to treatment with oral carbohydrate when trying to avoid unnecessary caloric intake.

Mean Levels and Variability in Affect, Diabetes Self-Care Behaviors, and Continuously Monitored Glucose: A Daily Study of Latinos With Type 2 Diabetes.

OBJECTIVE: This study investigated between- and within-person associations among mean levels and variability in affect, diabetes self-care behaviors, and continuously monitored glucose in Latinos with type 2 diabetes. METHODS: Fifty participants (M [SD] age = 57.8 [11.7] years, 74% women, mean [SD] glycosylated hemoglobin A1c = 8.3% [1.5%]) wore a "blinded" continuous glucose monitor for 7 days, and they responded to twice daily automated phone surveys regarding positive affect, negative affect, and self-care behaviors. RESULTS: Higher mean levels of NA were associated with higher mean glucose (r = .30), greater percent hyperglycemia (r = .34) and greater percentage of out-of-range glucose (r = .34). Higher NA variability was also related to higher mean glucose (r = .34), greater percent of hyperglycemia (r = .44) and greater percentage of out-of-range glucose (r = .43). Higher positive affect variability was related to lower percentage of hypoglycemia (r = -.33). Higher mean levels of self-care behaviors were related to lower glucose variability (r = -.35). Finally, higher self-care behavior variability was related to greater percentage of hyperglycemia (r = .31) and greater percentage of out-of-range glucose (r = -.28). In multilevel regression models, within-person increases from mean levels of self-care were associated with lower mean levels of glucose (b = -7.4, 95% confidence interval [CI] = -12.8 to -1.9), lower percentage of hyperglycemia (b = -0.04, 95% CI = -0.07 to -0.01), and higher percentage of hypoglycemia (b = 0.02, 95% CI = 0.01 to 0.03) in the subsequent 10-hour period. CONCLUSIONS: Near-to-real time sampling documented associations of glucose with affect and diabetes self-care that are not detectable with traditional measures.

Effect of Continuous Glucose Monitoring on Glycemic Control in Adults With Type 1 Diabetes Using Insulin Injections: The DIAMOND Randomized Clinical Trial.

Importance: Previous clinical trials showing the benefit of continuous glucose monitoring (CGM) in the management of type 1 diabetes predominantly have included adults using insulin pumps, even though the majority of adults with type 1 diabetes administer insulin by injection. Objective: To determine the effectiveness of CGM in adults with type 1 diabetes treated with insulin injections. Design, Setting, and Participants: Randomized clinical trial conducted between October 2014 and May 2016 at 24 endocrinology practices in the United States that included 158 adults with type 1 diabetes who were using multiple daily insulin injections and had hemoglobin A1c (HbA1c) levels of 7.5% to 9.9%. Interventions: Random assignment 2:1 to CGM (n = 105) or usual care (control group; n = 53). Main Outcomes and Measures: Primary outcome measure was the difference in change in central-laboratory-measured HbA1c level from baseline to 24 weeks. There were 18 secondary or exploratory end points, of which 15 are reported in this article, including duration of hypoglycemia at less than 70 mg/dL, measured with CGM for 7 days at 12 and 24 weeks. Results: Among the 158 randomized participants (mean age, 48 years [SD, 13]; 44% women; mean baseline HbA1c level, 8.6% [SD, 0.6%]; and median diabetes duration, 19 years [interquartile range, 10-31 years]), 155 (98%) completed the study. In the CGM group, 93% used CGM 6 d/wk or more in month 6. Mean HbA1c reduction from baseline was 1.1% at 12 weeks and 1.0% at 24 weeks in the CGM group and 0.5% and 0.4%, respectively, in the control group (repeated-measures model P < .001). At 24 weeks, the adjusted treatment-group difference in mean change in HbA1c level from baseline was -0.6% (95% CI, -0.8% to -0.3%; P < .001). Median duration of hypoglycemia at less than <70 mg/dL was 43 min/d (IQR, 27-69) in the CGM group vs 80 min/d (IQR, 36-111) in the control group (P = .002). Severe hypoglycemia events occurred in 2 participants in each group. Conclusions and Relevance: Among adults with type 1 diabetes who used multiple daily insulin injections, the use of CGM compared with usual care resulted in a greater decrease in HbA1c level during 24 weeks. Further research is needed to assess longer-term effectiveness, as well as clinical outcomes and adverse effects. Trial Registration: clinicaltrials.gov Identifier: NCT02282397.

Can composite digital monitoring biomarkers come of age? A framework for utilization.

INTRODUCTION: The application of digital monitoring biomarkers in health, wellness and disease management is reviewed. Harnessing the near limitless capacity of these approaches in the managed healthcare continuum will benefit from a systems-based architecture which presents data quality, quantity, and ease of capture within a decision-making dashboard. METHODS: A framework was developed which stratifies key components and advances the concept of contextualized biomarkers. The framework codifies how direct, indirect, composite, and contextualized composite data can drive innovation for the application of digital biomarkers in healthcare. RESULTS: The de novo framework implies consideration of physiological, behavioral, and environmental factors in the context of biomarker capture and analysis. Application in disease and wellness is highlighted, and incorporation in clinical feedback loops and closed-loop systems is illustrated. CONCLUSIONS: The study of contextualized biomarkers has the potential to offer rich and insightful data for clinical decision making. Moreover, advancement of the field will benefit from innovation at the intersection of medicine, engineering, and science. Technological developments in this dynamic field will thus fuel its logical evolution guided by inputs from patients, physicians, healthcare providers, end-payors, actuarists, medical device manufacturers, and drug companies.

Changes in HbA1c and Weight Following Transition to Continuous Subcutaneous Insulin Infusion Therapy in Adults With Type 1 Diabetes.

BACKGROUND: Historically, intensive insulin therapy for type 1 diabetes (T1D) has improved glycemic control at the risk of adverse weight gain. The impact of continuous subcutaneous insulin infusion therapy (CSII) on weight in the current era remains unknown. We assessed changes in hemoglobin A1c (HbA1c) and weight in adults with T1D transitioning to CSII at 2 diabetes centers in Denmark and the United States. METHODS: Patients with T1D, aged ≥18 years, managed with multiple daily injections (MDI) who transitioned to CSII between 2002 and 2013 were identified using electronic health record data from the Steno Diabetes Center (n = 600) and Joslin Diabetes Center (n = 658). Changes in HbA1c and weight after 1 year was assessed overall and by baseline HbA1c cut points. Multivariate regression assessed correlates of HbA1c reduction. RESULTS: In adults with T1D transitioning to CSII, clinically significant HbA1c reductions were found in patients with baseline HbA1c 8.0-8.9% (Steno, -0.7%; Joslin, -0.4%) and baseline HbA1c ≥9.0% (Steno, -1.1%; Joslin, -0.9%) ( P < .005 for all). Overall, there was no significant change in weight after 1 year at either center. Modest (<2%) weight gain was noted in patients with baseline HbA1c ≥9% at Steno (1.1 ± 0.3 kg, P < .0001) and Joslin (1.7 ± 1.1, P < .005). In multivariate models, HbA1c reduction was associated with higher HbA1c, older age, female sex at Steno ( R2 = .28, P < .005), but only higher baseline HbA1c at Joslin ( R2 = .19, P < .005). CONCLUSION: Adults with T1D with suboptimal glycemic control significantly improved HbA1c without a negative impact on weight 1 year after transitioning from MDI to CSII.